Veterans at Abbott
Abbott Senior Manager, Operations Quality Engineering in Plano, Texas
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
We are seeking an experienced, high caliber Senior Manager, Operations Quality Engineering. Working within broad objectives, the Manager is responsible for Operations Quality Engineering (QE) personnel and functional support of Product Development Programs (PDP) starting with design transfer to manufacturing, Continuous Improvement/Continuation Engineering (CI/CE), management of Operations Quality aspects of Production and Process Control activities, including Operations related CAPA / NCMRs, audit readiness, etc. Specifically, the Manager is responsible for providing oversight, coaching and guidance for QE teams with regard to PDP planning and execution of assigned deliverables, and cross-functional support of other tasks, for the program(s). These may include but are not limited to: Requirements Definition; Design input and output requirements/matrix; Standards Compliance Identification/Assessment; Product Life-Cycle Process Risk Management Activities; Process Validation activities; Test Method/Inspection Method Development and Validation; Operations related CAPA / NCMRs, audit readiness, participation in a Value stream-based environment with Production and Manufacturing Engineering partner organizations.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on Abbott:
Hires and retains a diverse, highly qualified staff and provides coaching, mentoring, career development and ongoing performance feedback throughout the operating year
Ensures and maintains a safe and professional work environment
Assigns and reviews project work of staff, sets work and resourcing priorities, and, as required, reviews and/or course corrects the output of project/program deliverables
Analyzes projects for resource requirements and ensures resource availability to all priority projects
Prepares project quality plans including milestones, validation of design and processes, as well as appropriate documentation and procedures
Manages/conducts special analyses and/or staffing of projects as required by the business
Facilitates resolution of problems, issues and/or risks including identification of root causes to prevent re-occurrence
Responsible for budgeting/cost control, personnel management, space and equipment acquisition/maintenance, communication and policy implementation/adherence
Complies with U.S. Food and Drug Administration (FDA) and other international regulatory regulation requirements/standards, Company policies, operating procedures, processes, and task assignments
Maintains positive and cooperative communications and collaboration with all levels of employees, customers (internal cross-functionally and external), contractors, and vendors
Performs other related duties and responsibilities, as assigned by Senior Leadership/Management
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
A Bachelor's degree (preferably in an applicable engineering discipline) with ten (10) or more years of progressively increasing responsibility and work experience in Quality Design, Engineering, and/or Research & Development in the medical device manufacturing industry
Five (5) or more years of service with increasing responsibility within a management/leadership role (preferably in Quality Design and/or Engineering)
Broad cross-disciplinary and in-depth knowledge and experience with industry accepted quality assurance design methodologies, project management, and product life-cycle risk management theory and practical application
Direct ‘hand’s-on’ medical device product development experience
Experience working in a broader enterprise/cross-divisional/matrixed business unit model preferred
Ability to work collaboratively within a geographically diverse business environment and personnel base
Strong leadership skills, including the ability to set and administer goals, provide positive, constructive, and consistent feedback respectfully, the capability to build positive relationships to improve business results, as well as coach, mentor and develop junior-level engineering staff
Ability to work effectively within a team in a fast-paced, ever-changing environment
Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchical levels in the organization
Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, staff, and others accountable
Strong organizational, strategic planning, and tactical execution/follow-up skills
Ability to maintain regular and predictable attendance
Your preferred qualifications and education:
Advanced degree in Mechanical, Electrical or Biomedical Engineering / Design
Advanced credential(s) in a relevant Quality/Engineering discipline/concentration. Ex: Professional certification or designation, such as CQE, CSQE, CRE and/or CMQ/OE
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com